Direct Biologics Granted FDA Approval of Third IND Application for the Use of ExoFlo in Mild-to-Moderate COVID-19 Infusion Therapy

Extracellular vesicle product ExoFlo clinical trials to address early-stage COVID-19.

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Jun 29, 2021, 15:30 ET

AUSTIN, Texas, June 29, 2021 /PRNewswire/ -- Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that the U.S. Food and Drug Administration (FDA) has approved the application for a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of mild-to-moderate COVID-19. This is Direct Biologics' third FDA-approved IND clinical trial, and it represents the very first IND approved by the FDA to investigate the use of extracellular vesicles (EVs) to treat mild-to-moderate COVID-19.

Evaluation and management of COVID-19 depend on the severity. Patients with risk factors for progression to severe COVID-19 are currently considered for monoclonal antibody treatment. However, with the emergence of viral mutants, expanding the arsenal of clinical treatments available may be critical for preventing another spike of the pandemic. In light of this, Direct Biologics will commence with Phase I/II trial for mild-to-moderate COVID-19, called EMOTE COVID-19, later in 2021. EMOTE (Early Mild Outpatient Treatment with ExoFlo) for COVID-19 is a double-blinded, placebo-controlled, randomized clinical trial.

According to Mark Adams, Co-Founder and Chief Executive Officer, "The FDA's approval to initiate our third IND trial of ExoFlo for treatment of COVID-19 represents a significant milestone for Direct Biologics. Our momentum initiating ongoing clinical trials signifies our commitment to delivering solutions for patients who have been affected in multiple ways by COVID-19."

Direct Biologics has successfully completed two clinical trials evaluating ExoFlo for the treatment of COVID-19-related acute respiratory distress syndrome (ARDS) in inpatient and ICU settings under its first IND and an expanded access or compassionate use protocol. The company also recently received approval to proceed with a Phase I/II trial for post-acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome.

About ExoFlo

ExoFlo is an investigational new drug that has not been approved or licensed by the FDA. It is an extracellular, vesicle-based biologic product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.

About Direct Biologics

Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of cutting-edge biologic technologies. Direct Biologic's management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next-generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process. For more information, visit www.directbiologics.com.

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